LAVAL, QC, May 12 /CNW Telbec/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company") held its Annual and Special Meeting of Shareholders today. President and Chief Executive Officer Roberto Bellini provided shareholders with updates on the Company's new development-focused business model, on the status of products in the development pipeline, on VIVIMIND(TM) and on the finances of the Company.
"I am pleased to lead BELLUS Health into its next business phase," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "Our new development-focused business model emphasizes what the Company does best: bringing products from the pre-clinical phase through proof-of-concept Phase II studies.
"In collaboration with our partner Celtic Therapeutics, we are advancing our product candidate KIACTA(TM) through a Phase III clinical trial at no development cost to BELLUS Health. In addition, we are targeting the development of a prodrug for Alzheimer's disease. We are optimistic that our expertise and experience in this field will help us succeed.
"Both of these programs fit squarely in our new business strategy of developing product candidates until their safety and efficacy have been demonstrated; and then entering into partnerships to finance late-stage studies. Overall, we believe this strategy will result in less risk, and more benefit, for our shareholders," Mr. Bellini concluded.
Pharmaceutical Development Pipeline
On April 29, 2010, BELLUS Health signed definitive transaction agreements with global pharmaceutical fund Celtic Therapeutic pursuant to which Celtic Therapeutics acquired and licensed worldwide rights related to KIACTA(TM) (eprodisate) for upfront payments of US$10 million, and will fund 100% of KIACTA(TM)'s development costs through its confirmatory Phase III clinical study and other development activities, estimated at an additional US$20 million. Celtic Therapeutics will also complete all other requirements for KIACTA(TM)'s regulatory approval and will conduct an auction process for the commercialization rights of KIACTA(TM). The overall proceeds of the auction process are expected to be shared equally between the parties.
KIACTA(TM) is being developed for the treatment of AA amyloidosis, a life-threatening orphan disease whose most common clinical presentation is renal dysfunction that often rapidly leads to dialysis and eventually death.
NRM8499 Prodrug Candidate
On March 30, 2010, BELLUS Health initiated a Phase I clinical study for NRM8499, a prodrug of tramiprosate intended for the treatment of Alzheimer's disease, which affects more than 30 million patients worldwide. The Company is expecting the results of this clinical study during the second half of 2010.
NRM8499 was identified by BELLUS Health as a compound that increases brain exposure to tramiprosate, which the Company believes may help improve the therapeutic effect on cognitive function and other clinical outcomes of Alzheimer's disease.
The knowledge acquired by BELLUS Health through its earlier clinical development of tramiprosate, along with its deep understanding of Alzheimer's disease, leads the Company to believe that the potential for NRM8499 is promising.
NC-503 (eprodisate disodium)
BELLUS Health announced on May 4, 2010, that further to its review of the results of the recently completed Phase IIa clinical proof-of-concept study evaluating NC-503 (eprodisate disodium) as a treatment for Type II diabetes, the Company has decided to discontinue the NC-503 diabetes development program. The study did not meet its primary efficacy endpoint.
While disappointing, this decision ensures that financial and human resources are being used for existing projects believed to have high potential for success, and possibly to invest in new ones.
OVOS Natural Health - VIVIMIND(TM)
In 2009, OVOS Natural Health, BELLUS Health's wholly owned subsidiary, obtained regulatory approvals for the commercial sale of VIVIMIND(TM) (homotaurine) in Italy and in Spain. It also filed a premarket notification of a New Dietary Ingredient for homotaurine with the U.S. Food and Drug Administration, and is pursuing mandatory associated regulatory activities to obtain marketing approval for homotaurine as a dietary supplement in the United-States. In Canada, OVOS Natural Health recently decided to make the brand available only online.
Now that a partnership has been concluded for KIACTA(TM), one of the Company's major priorities is to find a partner for the commercialization of VIVIMIND(TM) on a global scale. Discussions with potential partners are ongoing.
VIVIMIND(TM) is a science-based natural health product that has been shown to protect memory function. The science behind VIVIMIND(TM) was once again corroborated by two publications in the Journal of Nutrition, Health and Aging. VIVIMIND(TM) was voted the 2010 "Product of the Year" in the health care supplements category by more than 12,000 Canadian consumers.
BELLUS Health also provided shareholders with an update on the substantially improved financial position of the Company.
As at March 31, 2010, the Company had available cash and cash equivalents of C$11.2 million. Since that date, a first instalment of US$5 million was received from Celtic Therapeutics pursuant to the April 29, 2010, agreement entered into between the Company and Celtic Therapeutics with respect to KIACTA(TM). A second US$5 million instalment is payable by Celtic Therapeutics on October 29, 2010.
The cost reducing measures implemented in 2009 and the Company's continuous diligence with respect to costs have allowed it to reduce its burn rate to approximately C$1.5 million per month, based on financial data for the first quarter of 2010. Assuming that current financial conditions will remain constant, the Company does not expect any additional financing to be required until the third quarter of 2011.
Board of Directors
BELLUS Health welcomed Mr. Franklin Berger to the Board of Directors. Mr. Berger is joining Dr. Francesco Bellini, Chairman, Mr. Charles Cavell, Deputy Chairman, Mr. Roberto Bellini, Mr. Neil Flanzraich, Ms. Hélène F. Fortin, Mr. Pierre Larochelle and Mr. Joseph Rus on the Company's Board.
About BELLUS Health
BELLUS Health is a global health company focused on the research and development of products to provide innovative health solutions to address critical unmet medical needs. For further information, please visit www.bellushealth.com.
Forward Looking Statements
Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond BELLUS Health Inc.'s control. Such risks include but are not limited to: the impact of general economic conditions, general conditions in the pharmaceutical and/or nutraceutical industry, changes in the regulatory environment in the jurisdictions in which the BELLUS Health Group does business, stock market volatility, fluctuations in costs, and changes to the competitive environment due to consolidation, that actual results may vary once the final and quality-controlled verification of data and analyses has been completed, as well as other risks disclosed in public filings of BELLUS Health Inc. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements. The reader should not place undue reliance, if any, on any forward-looking statements included in this news release. These statements speak only as of the date made and BELLUS Health Inc. is under no obligation and disavows any intention to update or revise such statements as a result of any event, circumstances or otherwise, unless required by applicable legislation or regulation. Please see the Annual Information Form of BELLUS Health Inc. for further risk factors that might affect the BELLUS Health Group and its business.
SOURCE BELLUS Health Inc.
For further information: For further information: Anne-Marie Durand, NATIONAL Public Relations, (514) 843-2319